Molgramostim

Recombinant Human Granulocyte Macrophage Colony Stimulating Factor (GM CSF)Rx: PrescriptionCompound: Investigational

Also known as: CSF2 recombinant, GM-CSF, Leucomax, Molgradex, rhu GM-CSF (E. coli)

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Molgramostim is a recombinant human GM-CSF (non-glycosylated, produced in E. coli) that stimulates myeloid cell production and function. It has been investigated for neutropenia, pulmonary alveolar proteinosis (PAP), and other indications. It has been approved in some jurisdictions for myelosuppression-related conditions but remains investigational for newer indications such as autoimmune PAP via inhaled delivery.

Mechanism of Action

Binds to the GM-CSF receptor (CSF2R) on hematopoietic progenitor cells, stimulating proliferation, differentiation, and activation of neutrophils, eosinophils, monocytes, and macrophages; also enhances phagocytic and cytotoxic activity of mature myeloid cells.

Routes of Administration

InhaledIntravenousSubcutaneous

Goals & Uses

  • Treatment of aplastic anemiaHematologyLow
  • Bone marrow transplant supportHematology/OncologyModerate
  • Treatment of chemotherapy-induced neutropeniaHematologyHigh
  • Infectious disease adjunct (COVID-19)Infectious DiseaseLow
  • Treatment of autoimmune pulmonary alveolar proteinosis (aPAP)PulmonologyModerate

Contraindications

  • Concurrent myeloid malignancyOncologyHigh
  • Hypersensitivity to GM-CSF or E. coli-derived proteinsAllergy/ImmunologyHigh
  • Active autoimmune conditions (non-PAP) without monitoringImmunologyModerate
  • Excessive myeloid blast count (>10%) or leukemiaOncologyHigh

Adverse Effects

  • Fever and flu-like symptomsConstitutionalCommon
  • Cough/bronchospasm (inhaled route)PulmonaryCommon
  • Injection site reactionsLocalCommon
  • Capillary leak syndromeVascularRareLeakage of fluid from blood vessels into tissues
  • Pleural/pericardial effusionCardiovascular/PulmonaryUncommon
  • Bone pain / musculoskeletal painMusculoskeletalCommon

Drug Interactions

  • Myelosuppressive chemotherapy agentsModerate
  • CorticosteroidsModerate
  • LithiumLow

Population Constraints

  • Pediatric patientsAgeRelative
  • Pregnant womenReproductiveRelative
  • Patients with autoimmune disease historyImmunologyRelative
  • Renal or hepatic impairmentOrgan DysfunctionRelative

Regulatory Status

  • European UnionInvestigationalPreviously marketed as Leucomax in some EU countries; marketing authorizations lapsed. Molgradex (inhaled) under EMA regulatory pathway for aPAP.
  • United StatesInvestigationalNot FDA-approved; sargramostim is the approved GM-CSF. Inhaled molgramostim (Molgradex) under FDA review/investigation for aPAP.
  • United KingdomUnknownHistorical approval as Leucomax has lapsed; current status as standalone product uncertain post-Brexit.

Approved in some European and other countries historically for chemotherapy-induced neutropenia; sargramostim (yeast-derived, glycosylated) is the FDA-approved GM-CSF in the US. Molgramostim (inhaled) is under active investigation in the EU and US for autoimmune pulmonary alveolar proteinosis (IMPALA trials).

Evidence & Sources

No sources recorded yet.

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